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Group 1.3 Relationships between RECs in multi-centre, international studies –problems and solutions

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Do RECs ever communicate with one another? Population genetics – RECs are told that information is proprietary and confidential, but sponsors will approve communication between RECs –What is proprietary information? –Adverse events as proprietary results? Competitive advantage of not sharing SAE may be significant; not necessarily means suppression of information In clinical trials, it is more difficult, there are no guidelines for communication among REC Is reporting efficient or consistent? Role of sponsors

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Regulations may provide that sponsors inform if they have submitted studies to other RECs, but there is not much communication between/among RECs At the national level, issues discussed are not generally known, just if a study has been approved or not Informed consent may be changed locally but not the protocol itself There is no official mechanism for communication among RECs

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Reporting of adverse events is crucial to know among the different sites in multi- centre clinical trials – the role of a DSMB supposedly will monitor this centrally –In US DSMB is practically a requirement, it is taken very seriously –Sometimes they dont work so well International organizations (WHO) could fill this role

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Shopping among RECs An interesting proposal is to create national list of studies available to everyone – –Some countries do have it Scrutiny of the media is a big issue Lack of knowledge among RECs allowsshopping on the part of sponsors

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One- or two tier models In transition countries: –There are laws, but no instruments to apply laws. RECs are being created –Little experience on research ethics in general - few know about this – important training needs

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When centres are in different countries, two-tier approach is important –Broad ethical issues –Local RECs put the particular study into context Particularly informed consent issues Any local regulatory issues

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Nordic countries: very good 2-tier system –Central committee that coordinates, not reviews –Central committee composed of heads of regional committees, that approves studies first –Collect information on issues to be discussed –Inspect international clinical trials, a help to committees for prevention of future mistakes –Use of international guidelines that should be in local languages

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Two tier system may be applied differently, for example REC inspects animal experiments as well A regulatory agency that can closed down an institute if found non-compliant in any area is a strong incentive to do things right (ej OHSP) China: one IRB can review a multi-centre protocol in general then the other local IRBs will approve – local IRB monitors SAE but central IRB Central IRBs talk to media; local IRBs will usually keep to themselves

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Relationships between RECs in developed and developing countries Are there any relationships? Institutions have to accept protocols because it is too cumbersome to change them, otherwise they loose the opportunity Important to have researchers participate in writing of proposals so the research is designed appropriately from the start

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Establish more relationships to cooperate on ethical issues, prepare people in advance and involve them before protocols are designed –Include issues on social, medical, etc. problems

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Standard of care issue before, during and after the trial Does this mean standard of care in your country? More clarity on the role of REC: example: follow-up screened but rejected participants in HIV vaccine trials because they were sero-positive? –Issue of life-long follow-up

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Protocol needs to specify everything clearly Undue burdens on companies have to be considered Solution: establishing some kind of partnering, including other efforts going on simultaneously, for example, foundations working on the same pathologies (ie HIV)

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Other considerations Difficult to always meet first-world standard of care Risk-benefit balance is crucial. Amount of incentives offered must be considered Care in research is a direct or indirect incentive Harm a research project can have on a community